NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

NCT01085292 | Completed Phase 1 DMC

• 2 other identifiers: SNOXE36C1012010-019148-38
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective of this trial is to evaluate the safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus. A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic response at the level of inflammation, metabolism as well as ongoing diabetes complications (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to provide sufficient safety and dose-response data for a planned Phase IIa proof of concept study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus

  4 weeks

Secondary Outcomes (1)

• Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus

  4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Drug: NOX-E36

Group B - D

EXPERIMENTAL

Drug: NOX-E36

Interventions

NOX-E36 DRUG

Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group A: Healthy male and female subjects
• Group B-D: Patients with type 2 diabetes mellitus according to ADA definition; GFR \> 60 mL/min; HbA1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria

You may not qualify if:

• History of or presence of clinically significant diseases with the exception of diabetes (Groups B-D)
• Concurrent illness that may affect blood glucose other than diabetes
• Supine blood pressure at screening, after resting for 5 min, of \>140 mmHg systolic or \> 90 mmHg diastolic (Group A) or \> 160 mmHg systolic or \> 95 mmHg in diabetes mellitus patients (Groups B-D)
• Clinically significant abnormal ECG at screening
• Any kidney disease not caused by diabetes or hypertension
• Type 1 diabetes mellitus

Sponsors & Collaborators

• TME Pharma AG: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator

Study Sites (5)

Itecra GmbH

Cologne, 50931, Germany

Location

CTC North MediGate GmbH

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

ikfe GmbH

Mainz, 55116, Germany

Location

Profil Institut fuer Stoffwechselforschung GmbH

Neuss, D-41460, Germany

Location

Related Publications (1)

• Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

  PMID: 30957581 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Grit Landgraf, PhD

  Noxxon AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

DE (5)